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Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial

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ClinicalTrials.gov Identifier: NCT01851057
Recruitment Status : Recruiting
First Posted : May 10, 2013
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs (AEDs) as prescribed (i.e., non-adherence). Non-adherence, which is modifiable, is associated with continued seizures, mortality, poor quality of life, and high healthcare costs. There are no adherence interventions for young children with epilepsy and their families; thus, the current proposal examines a family-based behavioral treatment focused on improving epilepsy knowledge and problem-solving around barriers to adherence in young children with epilepsy and their families with the goal of improving adherence and ultimately, seizures and quality of life. It is hypothesized that children with newly diagnosed epilepsy and their families who participate in the problem-solving intervention will have significant improvements on adherence compared to those in the education only intervention.

Condition or disease Intervention/treatment
Epilepsy Behavioral: STAR Behavioral: Education Only

Detailed Description:
Non-adherence to antiepileptic drugs (AEDs) is a common (i.e., 58% of patients have some level of non-adherence) and previously under-recognized problem for young children with newly diagnosed epilepsy. This is surprising given the consequences of non-adherence in patients with epilepsy are extremely serious, including continued seizures, mortality, and high healthcare expenditures. Despite the critical need to develop and implement interventions to improve adherence, there are no family-based interventions for young children with epilepsy and their families. As such, we developed a family-tailored adherence intervention (STAR: Supporting Treatment Adherence Regimens) focused on increasing epilepsy knowledge and problem-solving skills around barriers to adherence for children with epilepsy and their families. Data from our pilot adherence intervention studies demonstrated good preliminary effects (effect size= 0.64) and excellent feasibility, with families reporting that the intervention was beneficial and a positive experience for their family. Capitalizing on these findings, the next logical step is to test the efficacy of the STAR intervention to improve AED adherence in 200 children with epilepsy via a randomized controlled trial. Thus, the aims of the study are to examine the short-term and long-term effects of the STAR intervention on electronically-monitored medication adherence in children with new-onset epilepsy compared to an education only (EO) intervention. In addition, exploratory aims are to examine the effect of the STAR intervention on seizure freedom and QOL in children with epilepsy compared to the EO intervention. The current study uses an innovative, sequential, randomization enrichment design that preventatively targets 200 patients with new-onset epilepsy, between 2-12 years, who demonstrate non-adherence. Using criteria established from our pilot studies, adherence falling below 95% within the first six months of the study will trigger participant randomization into one of two 8-session interventions: STAR or EO. If the aims of the project are achieved, this study will change the practice of pediatric epilepsy by providing a proven approach to the routine monitoring and treatment of AED non-adherence in epilepsy clinics across the nation. This study also lays the foundation for determining the long term impact of adherence intervention on morbidity and mortality. In addition, this study's innovative methodological enrichment design should be generalizable to other pediatric conditions and lead to the development of cost effective, clinic-based adherence promotion interventions.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial
Study Start Date : April 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Education Only
Education only arm (8 total sessions)
Behavioral: Education Only
Education around epilepsy (8 total sessions)
Experimental: STAR: Education and Problem Solving
Problem-solving and education intervention (8 total sessions)
Behavioral: STAR
Problem-solving and education intervention (8 total sessions)


Outcome Measures

Primary Outcome Measures :
  1. Adherence rate (short-term) [ Time Frame: 30 day post intervention adherence rate ]
    This is a measure of adherence, using an electronic monitor called the Medication Event Monitoring System (MEMS) TrackCap, and adherence rates range from 0 to 100%. Adherence rates will be calculated at baseline and represent a rate from 0 to 100. Similarly, an adherence rate will be calculated for the 30 day post intervention period, with a rate between 0-100%. The change score for the mean of the 30 days of adherence immediately following the end of intervention relative to the mean adherence obtained during the30 day screening period will be calculated.


Secondary Outcome Measures :
  1. Adherence rate (long-term) [ Time Frame: 3, 6 and 12 months post intervention ]
    This is a measure of adherence, using an electronic monitor called the MEMS TrackCap, and adherence rates range from 0 to 100%. The outcome will be a comparison of baseline 30 day adherence, which ranges from 0 to 100%, to the 3, 6, and 12 month post intervention adherence to antiepileptic drugs (0-100%). A change score will be calculated between the baseline and long-term end points of 3, 6 and 12 months.


Other Outcome Measures:
  1. Health related quality of life [ Time Frame: 6 and 12 months post intervention ]
    Compare baseline quality of life scores (0-100), based on the PedsQL (Pediatric Quality of Life) questionnaire, compared to 6 and 12 months post intervention.

  2. Seizure absence/presence [ Time Frame: 6 and 12 months post intervention ]
    Compare seizure absence/presence (0=no;1=yes) from baseline to 6 and 12 months post intervention


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ages 2-12 years
  • diagnosis of epilepsy within approximately 6 months
  • only one prescribed AED
  • family lives < 75 miles from Cincinnati Children's Hospital Medical Center (CCHMC)
  • ability to read English

Exclusion Criteria:

  • comorbid medical disorders requiring daily medication
  • parent-reported significant developmental delays (e.g. Autism)
  • liquid AED formulation due to electronic monitoring incompatibility.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851057


Contacts
Contact: Avani Modi, Ph.D. 513-636-4864 avani.modi@cchmc.org
Contact: Krista Mann (513)803-2745 krista.mann@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Krisa Mann    513-803-2745    krista.mann@cchmc.org   
Principal Investigator: Avani C Modi, Ph.D.         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Avani C Modi, Ph.D. Children's Hospital Medical Center, Cincinnati
More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01851057     History of Changes
Other Study ID Numbers: R01HD073115 ( U.S. NIH Grant/Contract )
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not being shared

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Epilepsy

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases